Main changes to the ABPI Code of Practice for the Pharmaceutical Industry and to the PMCPA Constitution and Procedure Main changes to the ABPI Code Agreed by ABPI Members 20 November 2014 To come into operation on 1 January 2015 Changes due to: EFPIA Disclosure Code Changes to EFPIA HCP Code Outcome of ABPI Board Review Regular updating/tidying up 2015 Code Operative on 1 January 2015. Transition period until 30 April 2015 to comply with newly introduced provisions. Main changes Clause 1 Scope and Definitions Clause 1.1 Supplementary Information and other consequential changes: ‘appropriate administrative staff’ replaced with ‘other relevant decision makers’ and definition added Main changes Clause 1 Reference to ‘electronic material’ and ‘social media’ added to examples of sales promotion Definition of ‘healthcare organisation’ (HCO) added Supplementary information to make clear that a HCO consisting only of one health professional or other relevant decision maker would be subject to requirements for individual health professionals Main changes Clause 1 Exception added in the event of a conflict of requirements with regard to the limits for subsistence in countries where the national association is a member of EFPIA and thus covered by EFPIA Codes as referred to in the supplementary information to Clause 19.2 Main changes Clause 2 Discredit to, and Reduction of Confidence in, the Industry ‘unacceptable payments’ added to the examples of activities likely to be in breach of Clause 2 Main changes Clause 3 Advance Notification of New Products or Product Changes Additional supplementary information making it clear advance notification relates to products which may significantly affect expenditure and that the effect on expenditure could be significant additional cost or savings Delete reference to 2-3 years in advance to meet treasury requirements Additional supplementary information requiring companies to ensure that advanced information is also provided wherever possible for inclusion in horizon scanning databases Main changes Clause 4 Prescribing Information and other Obligatory Information Bullet points reordered to make it clear that the cost where needed and the legal classification must be provided and that either the remainder of the current bullet points are provided or the summary of product characteristics in order to meet the requirements for prescribing information Main changes Clause 4 Prescribing Information and other Obligatory Information Clause 4.3 expanded to add similar requirements to those in Clause 4.6 for the non proprietary name in electronic advertising Main changes Clause 4 Prescribing Information and other Obligatory Information New Clause requiring that for digital material such as advertisements in electronic journals, emails, electronic detail aids and such like, the prescribing information may be provided either by inclusion in the digital material itself or by way of a clear and prominent direct single click link. Such links can only be used when material is generally expected to be viewed online Main changes Clause 4 Prescribing Information and other Obligatory Information Delete Clause 4.5 relating to audio material and requirements for advertisements in an independently produced electronic journal as these are now covered by other clauses Amend Clause 4.7 to make it clear it applies to printed material Main changes Clause 4 Prescribing Information and other Obligatory Information Add clarity regarding when reproducing the SPC would not be an acceptable way to meet requirements for prescribing information Add supplementary information regarding future changes to the adverse event reporting address Clarify that digital communications are also covered by the black triangle symbol and associated requirements Main changes Clause 7.5 Add clarity that when data from clinical trials is used as substantiation, the trial must be registered and the results disclosed as required by Clause 13.1 Main changes Clause 9 High standards, Format, Suitability and Causing Offence, Sponsorship Additional supplementary information regarding the use of inappropriate language, abbreviations or emoticons particularly in digital communications Delete reference to the provision of rubber stamps to doctors for use as aids to prescription writing Delete reference to defunct or superseded organisations, the ‘Medicines Commission, the Committee on Safety of Medicines, and the Medicines Control Agency Main changes Clause 9.9 Additional supplementary information providing clarity that similar arrangements for responding to emails apply if the enquiry is by letter but an email address is provided Additional supplementary information regarding prior permission when detailing remotely and associated requirements Main changes Clause 11 Distribution of Promotional Material Remove reference to promotional material. All material sent by a company should be relevant to the intended audience Main changes Clause 12 Disguised Promotion Add a reference to the supplementary information regarding promotional material sent electronically Main changes Clause 13 Non interventional studies Addition of ‘and commercially available’ to provide more guidance regarding when clinical trial results are required to be disclosed Amended to refer generally to the current Joint Positions rather than specific Joint Positions Main changes Clause 14 Certification Additional supplementary information allowing printed material to be certified electronically and only one of the two signatories to certify the final form Additional clarity regarding no need to certify meetings which involve travel outside the UK if the only involvement is sponsoring a speaker to present at the meeting Main changes Clause 14 Certification Clarification for certification of joint working documents, everything used during the development of the project should be of the same standard as certified material but only the final documents need to be certified Main changes Clause 14 Certification Replace ‘technical’ with relevant as it is relevant briefing material that should be certified Addition supplementary information regarding certification of digital material Additional clarity regarding certification of joint ventures and co-promotion Main changes Clause 15 Representatives Reference to electronic material added Main changes Clause 16 Training Clarification that an application for an extension regarding the representatives exam should be made on a form available from the PMCPA and should preferably be made by the company Main changes Clause 18 Items for Patients etc To be headed ‘Prohibition on Inducements and Inappropriate Payments and the Provision of Items for Patients, Health Professionals and Other Relevant Decision Makers Outcome Agreements and Patient Access Schemes’ Adjust content so that Clauses 18.4 and 18.6, 18.5 and 18.7 become three separate clauses Main changes Clause 18 Simplification of supplementary information re package deals Update General Medical Council guidance Update the Pharmaceutical Price Regulation Scheme date, reference to NICE and add reference to devolved nations Main changes Clause 18 Amend the supplementary information to make clear the differences between pens and pads at company organised meetings and pens and pads in conference bags. If pens and pads are provided for conference bags at third party organised meetings they are not allowed to include the company name Main changes Clause 18 Add to the supplementary information that transfers of value in relation to medical and educational goods and services must be disclosed Clarify certification requirements for joint working materials Main changes Clause 18 Clauses 18.4 and 18.6 to become Clause 19 Medical and Educational Goods and Services Clause 18.5 to become Clause 20 Joint Working Clause 18.7 to become Clause 21 Relationships and Contracts with Certain Organisations Main changes Clause 19 Meetings, Hospitality and Sponsorship Updated to allow premium economy flights in limited circumstances (flights scheduled to take longer than six hours) Remove reference to PGEA approved courses Main changes Clause 19 Meetings, Hospitality and Sponsorship Additional supplementary information clarifying that the maximum of £75 (plus VAT and gratuities) does not apply when a meeting is held outside the UK in a country where the national association is a member of EFPIA and thus covered by EFPIA Codes. In such circumstances the limits in the host country code would apply Main changes Clause 21 Transfers of Value Add reference to Clause 18.4 Clarification that the term ‘health professional’ in relation to disclosure of transfers of value also includes any employee of a pharmaceutical company whose primary occupation is that of a practising health professional Add the requirement that a central platform for disclosure in the UK must be used by companies Clarification that only payments to health professionals can be aggregated. Payments to healthcare organisations need to be given on an individual basis. Clause 23 Relations with the public and the media Add reference to social media to the supplementary information to Clause 23.2 Information to the Public. Add reference to NHS Choices, NHS III and devolved nations to supplementary information to Clause 23.4 Requests for Information or Advice on Personal Medical Matters. Clause 25 The Internet Add reference to the Joint Position on the Publication of Clinical Trial Results in the Scientific Literature 2015 Code Comes into operation on 1 January 2015 Transition period until 30 April 2015 for newly introduced requirements Main changes Constitution and Procedure Complainants encouraged to provide contact details rather than submitting anonymous complaints. Reference to promotional material and promotional activities deleted as the Code covers more than promotion Delete ‘practising’ as this is now covered by ‘registered’ with regard to the independent pharmacist on the Appeal Board Main changes Constitution and Procedure Notice of appeal may now be withdrawn by a complainant with the consent of the respondent company at anytime but if notice is given by a complainant company after the papers relating to its appeal have been circulated to the Appeal Board, then the higher administrative charge will be payable Refer to the Competition and Markets Authority instead of the Office of Fair Trading